Senior Manager, Regional Delivery Lead (RDL): Feasibility Support Manager (FSM)
Karuna Therapeutics
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
The Feasibility Support Manager (FSM) Regional Delivery Lead (RDL) is a role that will help drive accountability and delivery of Clinical Trial Feasibility – namely for non-priority trials. This role will represent all regions (e.g., Americas, EMEA, APAC) for assigned trials depending on country and site requirements. The FSM RDL directly works with Global Trial Managers, OPL, TAIP, Clinical Trial Managers, fellow RDLs and Regional Clinical Operations country leadership to support the completion of the feasibility process for multiple trials. The FSM Regional Delivery Lead is someone who is passionate for coordination and collaboration, experienced in global clinical trial delivery, able to contribute to strategic solutions and demonstrates strong communication skills.
- Drives the clinical trial feasibility process and decision-making for country, site, and patient allocations on behalf of all region in collaboration with global and country operational leaders. The primary focus will initially be for BMS non-priority trials.
- Will develop skills in AI-driven country and site feasibility and will then share this expertise with colleagues.
- Synthesizes data and is able to clearly articulate the implications of different scenarios (countries and sites selected) on study deliverables and timelines.
Key Responsibilities
Feasibility
- Supports the decision making for allocation of countries, sites and patients for insourced clinical trials in collaboration with global and country study leadership
- Drives the country- and site-feasibility processes within assigned regions for non-priority trials. This may extend to priority trials as the level of expertise increases.
- Involvement in CFQ and SFQ design and deployment.
- Communicates country perspectives on study feasibility to facilitate effective planning and assumptions when establishing milestones for a trial
- Monitors country progress during feasibility, escalates concerns to the global team and offers potential mitigation strategies.
- Responsible for clearly articulating timelines and monitoring the completion of work to these timelines.
- Ensures that relevant stakeholders are proactively notified of key feasibility decisions and proactively takes steps to adjust initial assumptions and plans as the need arises.
Relationship Management
- Proactively develops and maintains collaborative relationships with global and local stakeholders on multidisciplinary teams across leadership levels within the organization
- Ensures appropriate methods are used when communicating with key stakeholders and cross-functional partners
Leadership and Decision Making
- Holds self and others accountable by proactively communicating with key stakeholders and global/local teams, making timely and data-driven decisions while considering global and regional perspectives
- Prioritizes work and shifts priorities as needed, builds relationships and collaborates across teams, functions and geographies
- Focuses on delivering operational goals within strict deadlines
- Effectively manages multiple assigned trials at a given time and sets priorities with minimal guidance
- Understands interdependencies and effectively escalate issues with proposed solutions to appropriate global team in a timely manner
- Understands the upstream and downstream implications of decisions that affect study and regional outcomes and timelines; proactively communicates the implications with a proposed solution to the appropriate stakeholders
- Ability to focus on country level and study level work as situations arise and deliver high quality presentations to key stakeholders
- Proactively provides recommendations and perspectives when seeking guidance from GTMs and/or other global team members
Qualifications & Experience
Degree Requirements
- BA/BS or equivalent degree in relevant discipline
Experience Requirements
- Minimum of 5 years of project management experience in the pharmaceutical industry in country or regional operations required
- Experience in working across regional teams
- Demonstrated project leadership, management, and organizational skills with strong presentation and communication abilities
- Experience with electronic quality, compliance, and CTMS systems required
- IT/Data Analytical Experience strongly preferred
Technical Competency Requirements
- Clinical trial project management skills at a country or regional level with strong presentation and communication abilities
- Strong experience in the areas of feasibility processes.
- In depth knowledge of regulatory guidelines, drug development and clinical research processes in country and/or region
- Proven success in using oral/written communication skills to influence, inform, or guide others
- Computer skills – Microsoft applications including (but not limited to), Word and Excel and PowerPoint
- Proficiency in study tools including electronic system skills (e.g., CTMS, eTMF)
- Ability to manage multiple deliverables and nimbly respond to changing business demands
Travel and After Hours Requirements
- Minimal Travel
- Considering the global nature of this role, it will be necessary for regular meeting attendance that falls outside normal business hours.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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